Study on medicine shortage

Medicine shortages are becoming more common in many EU/EEA nations. Patients' treatment quality suffers as a result of shortages, and healthcare professionals and health systems are burdened with the task of identifying and providing alternative treatments. The European Commission requested an investigation of medications in short supply in the EU and their core causes, as well as an assessment of the current regulatory framework, in order to create potential legislative and non-legislative solutions. Data from national shortage registers, comprehensive interactions with key stakeholders, and published literature were analyzed for this study. It emphasizes that a lack of high-quality, standardised information about shortage monitoring at the national level makes full comparative analysis difficult. Despite the study's limitations, it reveals that medical shortages are common in the region, with the majority of them involving prescription drugs.

Let's take a look at the key information of this report

What is the main cause of shortage?

Quality and manufacturing issues are number one reason for shortage. This is not surprising because this includes all the aspects related to supply chain and many pharmaceutical companies say they've had issues with manufacturing capacity, as well as obtaining APIs, raw ingredients, and other components. The latter issues are more commonly documented in the production of generic drugs than in the production of novel medicines. In the Figure below there is a detailed list of the issues impacting the manufacturing process

Impact of Covid-19 on medicine shortage

The rise in demand for these drugs in the early stages of the pandemic resulted in lower stock levels in many hospitals, with many hospital pharmacists unable to supply demand in a timely way.  Anaesthetics, antibiotics, muscle relaxants, and drugs taken off-label to treat COVID-19 were among the pharmaceuticals affected, according to the EMA at the time.

Another factor was also related to many manufacturing facilities affected by quarantine of personnel. In China, a survey by the Institute for Supply Management conducted between February and March 2020 found that 50% of suppliers (across industries) were operating at only 50% capacity.

Definition of shortage is not uniform across countries leading to Medicine shortages must be defined and reported.

Within the EU, there are substantial disparities in how countries define a shortage, as well as differences in how and when these criteria are applied. In response to this issue, the EMA and the HMA released a joint "shortage" definition in 2019. Stakeholders generally see this as a positive step, while some argue that the definition fails to distinguish between critical and noncritical shortages. Member states' criteria and processes for notifying shortfalls, as well as the information they request, are not standardized. Information sharing and comparative analysis between countries are hampered by a lack of standardisation and harmonisation. It also generates inefficiencies for those in charge of shortage notification. Improved harmonisation is often regarded as a requirement for developing effective and adequately tailored interventions to prevent and reduce shortages.

Impact on patient

What is the impact downstream? Hospital and retail pharmacist hare reported that in most of the cases the patient will receive no treatment or reduced treatment. This highlights how much is important to address the route cause and forecast shortages.

Solution proposed by European Commission

The European Commission, indicated a detailed the solution in the report, in the text below it is reported in full text with the recommended actions

Recommendations

Following extensive consultation with stakeholders, a series of 16 solutions has been recommended to address different aspects of the issue of shortages. These solutions collectively cover areas related to the collection and sharing of data and information between parties, supply chain issues, market issues and mitigation strategies. Specifically, it is recommended for the European Commission, the EMA and/or Member States to:

• Establish and follow a centralised and harmonised EU-wide definition of medicine shortages

• Establish and mainstream harmonised reporting criteria for shortages, collecting sufficiently detailed information on key parameters (e.g. product details, MAH, details on the shortage and impact)

• Develop an EU-wide list of medicines for which shortages are the most critical and develop policies and/or regulations to improve their availability

• Set up stakeholder dialogue platforms for/between supply chain stakeholders, patients, and healthcare providers, respectively at Member States level

• Develop EU-wide and uniform legislation allowing for imposing financial sanctions if

notification requirements and/or supply responsibilities are not met

• Require greater transparency of industry supply quotas as well as parallel traders’ and

wholesalers’ transactions

• Require suppliers to have adequate shortage prevention and mitigation plans in place

• Introduce legal obligations for MAHs and wholesalers to maintain a safety stock of

(unfinished) products for medicines of major therapeutic interest at EU-level

• Adopt common principles for the introduction of national restrictions on intra-EU trade

• Allow for greater flexibilities for emergency imports of specific products in case of market

withdrawals and other critical shortages

• Incorporate requirements for having more diversified, multiple tenderers and thereby

supply sources in public procurement tenders

• For EU authorities to reduce the administrative and cost burden submission of postapproval changes

• Enable an accelerated mutual recognition procedure (MRP) within the EU

• Enable a (more) efficient Repeat Use Procedure

• Develop an EU-wide medicines packaging and labelling regulation that included flexibilities for digital leaflets and multi-country/multi-language packaging and labelling

• Include information about available alternative medicines in shortage databases

Implementation of these recommendations will require action by different sets of stakeholders, with some requiring coordination at the level of the European Commission or the EMA whilst others will need to be supported and coordinated by competent authorities or similarly responsible bodies in the Member States.

Full content is available here EW0121416ENN.en.pdf

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